Food Packaging Materials: Testing Quality Ass... !NEW!
Package testing or packaging testing involves the measurement of a characteristic or property involved with packaging. This includes packaging materials, packaging components,[1] primary packages, shipping containers, and unit loads, as well as the associated processes.
Food Packaging Materials: Testing Quality Ass...
Testing can be a qualitative or quantitative procedure. Package testing is often a physical test. With some types of packaging such as food and pharmaceuticals, chemical tests are conducted to determine suitability of food contact materials. Testing programs range from simple tests with little replication to more thorough experimental designs.
For some types of products, package testing is mandated by regulations: food. pharmaceuticals, medical devices, dangerous goods, etc. This may cover both the design qualification, periodic retesting, and control of the packaging processes. Processes may be controlled by a variety of quality management systems such as HACCP, statistical process control, validation protocols, ISO 9000, etc.
Package testing is often a formal part of Project management programs. Packages are usually tested when there is a new packaging design, a revision to a current design, a change in packaging material, and various other reasons. Testing a new packaging design before full scale manufacturing can save time and money.[5]
Many suppliers or vendors offer limited material and package testing as a free service to customers. It is common for packagers to partner with reputable suppliers: Many suppliers have certified quality management systems such as ISO 9000 or allow customers to conduct technical and quality audits. Data from testing is commonly shared. There is sometimes a risk that supplier testing may tend to be self-serving and not completely impartial.
Large companies often have their own packaging staff and a package testing and development laboratory. Corporate engineers know their products, manufacturing capabilities, logistics system, and their customers best. Cost reduction of existing products and cost avoidance for new products have been documented.[6]
The basis of packaging design and performance is the component materials. The physical properties, and sometimes chemical properties, of the materials need to be communicated to packaging engineers to aid in the design process. Suppliers publish data sheets and other technical communications that include the typical or average relevant physical properties and the test method these are based upon. Sometimes these are adequate. Other times, additional material and component testing is required by the packager or supplier to better define certain characteristics.
Laboratory tests can help determine the shelf life of a package and its contents under a variety of conditions. This is particularly important for foods, pharmaceuticals, some chemicals, and a variety of products. The testing is usually product specific: the mechanisms of degradation are often different. Exposures to expected and elevated temperatures and humidities are commonly used for shelf life testing. The ability of packaging to control product degradation is frequently a subject of laboratory and field evaluations.
Many products degrade with exposure to the atmosphere: foods, pharmaceuticals, chemicals, etc. The ability of a package to control the permeation and penetration of gasses is vital for many types of products. Tests are often conducted on the packaging materials but also on the completed packages, sometimes after being subjected to flexing, handling, vibration, or temperature.
Packages can degrade with exposure to temperature, humidity, time, sterilization (steam, radiation, gas, etc.), sunlight, and other environmental factors. For some types of packaging, it is common to test for possible corrosion of metals, polymer degradation, and weather testing of polymers. Several types of accelerated aging of packaging and materials can be accomplished in a laboratory.
Many packages are used for products that are sensitive to temperature. The ability of insulated shipping containers to protect their contents from exposure to temperature fluctuations can be measured in a laboratory. The testing can be of empty containers or of full containers with appropriate jell or ice packs, contents, etc. Ovens, freezers, and environmental chambers are commonly used for this and other types of packaging.
Package bar codes are evaluated for several aspects of legibility by bar code verifiers as part of a continuing quality program. More thorough validation may include evaluations after use (and abuse) testing such as sunlight, abrasion, impact, moisture, etc.
Shipping containers are often subjected to sequential tests involving a combination of individual test methods. A variety of standard test schedules or protocols are available for evaluating transport packaging. They are used to help determine the ability of complete and filled shipping containers to various types of logistics systems. Some test the general ruggedness of the shipping container while others have been shown to reproduce the types of damage encountered in distribution. Some base the type and severity of testing on formal studies of the distribution environment: instrumentation, data loggers, and observation. Test cycles with these documented elements better simulate parts of certain logistics shipping environments.
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Section C.02.010 outlines options for carrying out the testing required in section C.02.009. Sourcing raw materials is an important operation that requires specific and in-depth knowledge of the raw materials and their fabricator in order to maintain consistency and quality when fabricating drug product. Raw materials should come from reliable fabricators.
Importers of drug products must have on their premises in Canada evidence of GMP compliance of the foreign buildings where the fabrication, packaging/labelling and testing of APIs occurs. You can find additional guidance in Health Canada's guidance document How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).
Your quality control department is responsible for approving all raw materials, packaging materials and finished products. It is very important for this department to exercise adequate controls to ensure the quality of the end product.
Drug quality is directly dependent on packaging quality. If a drug product is presented in an inadequate package, the entire effort put into research, product development and manufacturing control is wasted. In many cases (such as metered-dose aerosols or injectables), packaging quality is critical to the overall performance and effectiveness of the drug product. Faults and non-compliance in the packaging and labelling of a drug product continue to be a cause of drug recalls.
Section C.02.017 outlines options for when you may carry out the testing or examination outlined in section C.02.016. As with raw materials, buying packaging materials is an important operation that must involve staff who have thorough knowledge of the packaging materials and vendor.
Section C.02.019 outlines options for carrying out the testing required in section C.02.018. The options vary depending on the activities performed and the location where fabrication, packaging/labelling and testing occurs. Paragraph C.02.019(1)(b) outlines requirements you must meet as a packager/labeller, distributor or importer of a drug if the finished product testing is done before receipt on your site. Paragraphs C.02.019(3) and C.02.019(4) describe exemptions to finished product testing.
If any licensable activity such as fabrication, packaging, labelling or testing is performed in a non-MRA country, the testing expectations once product is received in Canada automatically revert to those described under the section for Buildings in non-MRA countries.
Identity testing is not required for multiple shipments of the same finished product lot providing that the primary packaging/labelling and secondary packaging/ labelling of the entire batch has been completely processed as a single batch and not as partial packaging of the same bulk. Storage and transportation conditions must be evaluated for each shipment.
Retention samples serve as a record of the batch of finished product or raw material. They can be assessed in the event that concerns arise with a finished product or raw material batch during the shelf life of a product (e.g. a quality complaint, a query relating to compliance with the marketing authorization, a labelling/packaging query, or a pharmacovigilance report).
A Canadian firm does business with a foreign company, and that foreign company contracts out the fabrication, packaging and testing of a product. Is it acceptable to only have a written agreement between the Canadian firm and the foreign company, and not with the contract company?
Is it necessary to include a chemical identification test in a specification for a packaging component (such as a plastic bottle)? Must this chemical identification (ID) be conducted for each lot received? Would vendor certification be considered an acceptable substitution for testing upon receipt?
Otherwise, there is no specific requirement to perform the other tests after packaging (including potency). However, you must validate the manufacturing process to demonstrate that the packaging/filling operation does not change the quality of the product (including potency). Your validation data must also show that the homogeneity of a product is maintained by appropriate means throughout the entire filling process for dosage forms such as lotions, creams or other suspensions.
FDA has special concerns regarding the vulnerability of animal-derived ingredients to contamination by pathogenic agents (i.e., agents that can cause disease or illness in humans or other animals). As background, ingredients are also called components, and there are two categories of components used in finished pharmaceutical production: inactive ingredient (often called excipients) and active ingredient (often called active pharmaceutical ingredient (API)). For the purpose of this guidance, an animal-derived ingredient is a substance of animal origin used to manufacture a drug product. They are primarily derived from byproducts of food production and include extractions from certain animal material and milked animal fluids (e.g., venoms) and may even be human-derived. Products of animal cell cultures, including monoclonal antibodies and therapeutic proteins, are not considered animal-derived APIs for the purpose of this guidance. For additional information concerning biotechnology products, refer to ICH guidance for industry Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Ingredient manufacturers are responsible for the quality and safety of the material they produce for use in finished pharmaceuticals. Ingredients are drugs and drugs are required to conform with current good manufacturing practice (FD&C Act, section 501(a)(2)(B)). Finished pharmaceutical manufacturers are also responsible for their selection, qualification, and use of ingredients in finished pharmaceuticals (e.g., the CGMP regulations at 21 CFR part 211, subpart E). Ingredient and finished pharmaceutical manufacturers should fully understand the potential for pathogenic agent contamination beginning with the livestock processing establishment (LPE) and continuing through subsequent handling and processing, and establish stringent controls to prevent contamination. It is also essential that appropriate tests or examinations are developed and applied to detect contamination as part of any meaningful control program. References: 041b061a72